FDA 510(k) Application Details - K153082

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K153082
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	SPINEOLOGY, INC. 7800 3RD STREET N, SUITE 600 ST. PAUL, MN 55128 US Other 510(k) Applications for this Company
Contact	JACQUELINE A HAUGE Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2015
Decision Date	02/04/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review